Zero Contact ™ - The First FDA EUA Authorized At-Home Saliva
COVID-19 Test
The First FDA EUA Authorized
At-Home Saliva COVID-19 Test
Our self-collection testing kit for COVID-19 uses a hassle-free saliva sample to determine if your patients are infected with the SARS-CoV-2 virus. We’ve partnered with labs operating under the Emergency Use Authorization guidelines issued by the FDA. Our test kits include a complimentary priority return mailer for sending the sample to the lab. Within 72 hours of the lab receiving the sample, you will be faxed the result and the patient can access the result in their dashboard. If the result is positive, it is reported to appropriate authorities.
Collection Method:
Saliva Collection Tube
Digital Results Available Within:
72 hours of the lab receiving the sample
FDA Fact Sheet:
https://www.fda.gov/media/137774/download
How It Works:
Step 1: Order Test Kits
Assess your patients to determine who needs to receive a test kit. You may place the orders yourself or instruct your patients to purchase their own kit.
Step 2: Register Your Patients
You or your patient registers the kit per instructions. Your office will be faxed results as long as you or your patient enter your office’s fax number during the registration process.
Step 3: Patients Collect Samples
The patient takes the test. Then they send it to the lab using the included shipping return mailer.
Step 4: Await Results
The patient receives his or her results via our portal within 72 hours of the sample arriving at the lab. Your office is faxed a copy of the results. A positive test is reported to the appropriate authorities.
FDA Authorization
This test has been authorized by the FDA under an Emergency Use Authorization for use by authorized laboratories. This test has not been FDA cleared or approved. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.